Comparison of the FemoSeal® Arterial Closure Device to Manual Compression After Coronary Angiography (CLOSE-UP I)

September 5, 2013 updated by: Niels Ramsing Holm, Aarhus University Hospital Skejby

Comparison of the FemoSeal® Arterial Closure Device to Manual Compression After Coronary Angiography: the CLOSE-UP I Randomized Trial

Is the FemoSeal® closure device safer and more comfortable than manual compression for femoral artery access closure after coronary angiography?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Access site complication after coronary angiography is still a challenge in everyday practice. The FemoSeal® closure device has proven very safe as shown in the swedish SCAAR registry. This study is aimed to investigate, in a randomized design, if the FemoSeal® has an advantage in safety and efficacy over manual compression.

Study Type

Interventional

Enrollment (Actual)

1005

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus University Hospital Skejby

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient must be at least 18 years old
  • Patients undergoing femoral access coronary angiography
  • Patient must be competent for providing informed, written consent
  • Only 6F sheath

Exclusion Criteria:

  • Percutaneous coronary intervention
  • Intra coronary measurements (FFR, IVUS, OCT, NIR)
  • Groin hematoma before closure
  • Pseudoaneurysm or AV fistula
  • Significant stenosis of ilial or femoral artery
  • Prior peripheral artery surgery
  • INR > 3,0
  • Platelet count < 120 million per millilitre blood
  • Coagulopathy (bleeding disorder)
  • Thrombolysis in the last 24h
  • Planned heparin infusion after the procedure
  • Pregnancy
  • Uncontrolled hypertension > 200 mmHg / 110 mmHg
  • Femoral access device closure in the last 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FemoSeal®
Closure device for femoral artery access closure
Device: FemoSeal®
Closure device for femoral artery access closure
Active Comparator: Manual compression
Conventional manual compression
Other: Manual compression
Conventional manual compression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm.
Time Frame: 20 minutes, 1 hour and at discharge, pooled
20 minutes, 1 hour and at discharge, pooled

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm. Patient self-measurements.
Time Frame: 14 days
14 days
Composite of: major vascular complications necessitating surgical repair, A-V fistulation, pseudoaneurysm needing treatment, major bleeding needing transfusion and infection needing antibiotics .
Time Frame: 14 days
14 days
Time to hemostasis, from sheath removal to hemostasis is achieved
Time Frame: 14 days
14 days
Time from end of closure procedure to ambulation. 1h bedrest recommended.
Time Frame: 14 days
14 days
Device deployment failure
Time Frame: 20 minutes
20 minutes
Time to cessation of continuous minor oozing measured from the end of the closure procedure
Time Frame: 14 days
14 days
Need for repeated manual compression after end of the closure procedure
Time Frame: 14 days
14 days
Pain and discomfort measured on a numerical pain rating scale (0-10)
Time Frame: 20 min
20 min
Vasovagal reaction (clinical signs AND Systolic BP drop of more than 30 mmHg AND/OR pulse drop more than 30 b/min. AND reversible immediately after treatment by atropin, fluids)
Time Frame: 20 minutes
20 minutes
The patient seeking medical assistance for all-cause closure site related symptoms after discharge.
Time Frame: 14 days
14 days
Pain and discomfort measured on a numerical pain rating scale (0-10)
Time Frame: 1 hour
1 hour
Pain and discomfort measured on a numerical pain rating scale (0-10)
Time Frame: Discharge
Discharge
Pain and discomfort measured on a numerical pain rating scale (0-10)
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital Skejby

Collaborators

Vingmed Danmark A/S

Investigators

  • Principal Investigator: Niels R. Holm, MD, Aarhus University Hospital Skejby

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

October 16, 2009

First Submitted That Met QC Criteria

October 23, 2009

First Posted (Estimate)

October 26, 2009

Study Record Updates

Last Update Posted (Estimate)

September 6, 2013

Last Update Submitted That Met QC Criteria

September 5, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • M-20090101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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